Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03197740
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2017-06-22
Brief Title:
A Multinational Multi-center Randomized Double-blind Active Comparator Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimers Disease
Sponsor:
Icure Pharmaceutical Inc
Organization:
Icure Pharmaceutical Inc
Study Overview
Official Title:
A Multinational Multi-center Randomized Double-blind Active Comparator Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the efficacy and safety of donepezil transdermal patch in patients with mild to moderate Alzheimers disease
The primary objective is to demonstrate the non-inferiority of the test drug IPI-301 donepezil transdermal patch to the comparator Aricept tablet after 24 weeks of treatment in patients with mild to moderate Alzheimers disease in terms of improvement in cognitive function as assessed by the Alzheimers Disease Assessment Scale - Cognitive ADAS-cog and in terms of global assessment as assessed by Clinicians Interview Based Impression of Change plus Caregiver Input CIBIC-plus
The primary objective is to demonstrate the non-inferiority of the test drug IPI-301 donepezil transdermal patch to the comparator Aricept tablet after 24 weeks of treatment in patients with mild to moderate Alzheimers disease in terms of improvement in cognitive function as assessed by the Alzheimers Disease Assessment Scale - Cognitive ADAS-cog and in terms of global assessment as assessed by Clinicians Interview Based Impression of Change plus Caregiver Input CIBIC-plus
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None